CE Mark Certification
A CE Mark certificate is needed in order to market a medical device in the EU. This certificate verifies that the product is safe and performs as intended. The ISO 10993-1 standard prescribes a process for designing, testing, and documenting the biological safety of a medical device product. SAXOCON provides you with everything you need to plan, test, and document compliance with regulatory requirements, including:
- A Biological Evaluation Plan to describe and justify your test strategy
- The selection, screening, and characterisation of construction materials
- Assistance in scientific advisory meetings with regulatory bodies
- The selection of appropriate laboratories, review of protocols, and monitoring of tests according to the requirements in the ISO 10993-series
- A toxicological risk assessment of results
Why choose us?
SAXOCON services for medical device manufacturers give you access to:
- A multidisciplinary team of highly skilled toxicologists, material scientists, and supply chain professionals
- Extensive experience in state-of-the-art safety evaluations according to international standards and regional regulatory guidelines
- Safety evaluations based on proprietary information obtained from our world-wide network of materials suppliers
- Smart, cost-effective test strategies that bring your products to market in a timely manner
SAXOCON compiles all necessary documentation for the approval of your product in a Biological Evaluation Report.
Reusable medical devices
AAMI TIR12 compliant cleaning procedures.
Properly evaluate your materials.
Stay ISO 13485 and 14971 compliant.
PMT analysis for ISO 10993-19 compliance.